NHMRC Public Consultations

Skip Navigation and go to Content
Visit NHMRC website

Stem Cell Treatments: A quick guide for medical practitioners and FAQ: a resource for patients submission

ID: 
10
This submission reflects the views of
Organisation Name: 
Australasian Society for Stem Cell Research
Please identify the best term to describe the Organisation: 
Stem cell society
Personal Details
Questions
3. Does the document contain relevant information? If not, which sections do you consider to be irrelevant?: 

The Australasian Society for Stem Cell Research (ASSCR) supports this initiative by the NHMRC to publish information documents about stem cell treatments for medical practitioners and patients. It is clearly a role for the NHMRC to provide scientific evidence-based advice and information about the latest clinical applications from stem cell research. The information is relevant and timely.

4. Does the document exclude any important information that would be useful to medical practitioners or patients?: 

This document needs to better highlight that unproven stem cell treatments are being offered in Australia. It is crucial for Australian patients and medical practitioners to be aware that clinics in Australia are also offering unproven stem cell therapies. These clinics offering unproven treatments are not just based overseas. All of the same precautions described for international stem cell clinics apply to similar clinics based in Australia. 

6. How could general practitioners best access this information (i.e. an appropriate website)?: 

A website that provides updated information about stem cell treatments and including regulation and ethics guidelines as well as contacts.

Specific Comments
Specific Comments: 
Stem Cell Treatments - Q2


  • Suggest changing the first sentence to emphasise that adult stem cells are limited in their developmental potential:

Stem cells are a population of precursor cells that are capable of developing into many different cell types indicative of the organs and tissues, in which the stem cells reside

Stem Cell Treatments - Q3

 

  • The ASSCR would recommend the NHMRC clearly outline the current situation for patients considering these treatments, as follows:

The reality of stem cell treatments in Australia and around the world is that, beyond use of bone marrow stem cells for blood and certain immune related disorders, few of the stem cell treatments available are scientifically proven. The clinics or practitioners offering these treatments provide scant information about their procedures. They most likely collect a poorly defined mixture of cells and do not provide evidence of engraftment following transplantation. Further, there is no validation that the cells even have stem-cell likes properties. Therefore, despite their claims, most clinics are most likely not using ‘stem cells’ as part of their treatment. The commonly used terminology ‘stem cell tourism’ is misleading. 

 

  • The two examples of tumour development in patients after ‘stem cell’ injections are cautionary for patients deciding upon stem cell treatments and useful for inclusion in the draft document. However, these are rare cases, in particular in comparison to the large number of unproven and unregulated ‘stem cell’ treatments being carried out worldwide.

Suggest for the description of the first patient, to include that the boy travelled to Russia for the treatment and replace wording ‘intracerebellar and intrathecal’ with lay terms, for eg: “A thirteen year old boy treated with human fetal neural stem cells injected into the brain and the fluid that surrounds it, developed a multifocal brain tumour four years later.” 

 

Suggest including a sentence - As most of the procedures/practices for ‘stem cell’ treatments being carried out by clinics worldwide and in Australia, are not made publically available, evaluating long term safety studies are not possible. 

Stem Cell Treatments - Q4


As outlined above (response to Question 3), many of the treatments currently being offered in Australia would fall into the ‘unproven treatments’ category. Most of these treatments may not be utilising stem cells; there are very few stem cells in most tissues and they are difficult to isolate and define. Therefore, the isolation of tissue/cell mixtures with minimal manipulation will result in transplantation of ill-defined mixture of cells with no guarantee it contains stem cell populations. This is currently common practice in Australia, in particular for autologous treatments. Few clinics provide details of their procedures or any information about the efficacy.

Stem Cell Treatments - Q5


It is crucial for Australian patients and medical practitioners to be aware that clinics in Australia are also offering unproven stem cell therapies. These Australian-based clinics can also be identified by the common characteristics listed on p3. All of the same precautions described for international stem cell clinics apply to similar clinics based in Australia. Mostly, these clinics are isolating a patient’s own cells (autologous), which are then re-transplanted following minimal manipulation. A common example is the extraction of adipose tissue or fat cells by lipo-suction to allegedly treat osteo-arthritic conditions. 

Further, there are Australian based practitioners referring patients to clinics abroad for unproven treatments, so not all are ‘directly marketed to consumers’.

Suggest saying that it is very possible that Australian and international stem cell clinics currently in operation are probably not using stem cells. As discussed, the commonly used terminology ‘stem cell tourism’ is misleading. Despite their claims, most clinics are most likely not using ‘stem cells’ as part of their treatment.

Stem Cell Treatments - Q6


Quick tips for medical practitioners:

 Suggest the following changes:

Q1. remove this question as it is misleading.

(Undergoing a ‘stem cell’ treatment in Australia is not a guarantee the treatment is safe and effective. Further, there are highly reputable clinics overseas, offering clinical trials and evidence based treatments. The implication is that unlike overseas, treatments in Australia are effective and safe, which is incorrect.)

2. The three categories of ‘status of treatment’ need to be explained in more detail. This can be included in the Quick Guide and Frequently Asked Questions – A Resource for Patients.

3. Is there a scientific rationale?

    Outline further what this could mean by including examples in the Patient Checklist:

    for example 1 -  if the clinic says there is an improvement following treatment. Scientifically-based questions a patient could ask are –

  • for how many patients?
  • has this been measured?
  • Is the benefit short or long term?
  • is it better than existing treatments?

7. Suggest clarifying what a ‘specialist’ means. Is the expertise of the medical practitioner performing the procedure in the type of disease being treated? Is the person involved with the stem cell manipulation qualified in this area? What is their experience?

Frequently Asked Questions - Q1


Overall: Suggest that the Stem Cell Treatments – a quick guide for medical practitioners also include a section defining the types of stem cells.

Suggest re-writing the following sentence, “All of these cells originate from stem cells”, as it not accurate: You could write – In an adult, stem cells replace the specialised cells that make up the organ and tissue in which they reside.


1. What are stem cells?

Suggest rewording (not all stem cells become specialised, some divide into identical daughter cells, as shown in Figure 1) –

  • ‘Stem cells are cells which are not specialised. This means that they are not fully committed to becoming a particular cell fate, with a specific function.’ Include - Stem cells are restricted to becoming the cells that make up the organ and tissue in which they reside.
  • The ability for stem cells to differentiate and self-replicate is why researchers and medical practitioners believe stem cells will provide a new way to treat certain diseases and ailments. Stem cells can develop into functional specialised body cells and large numbers of them can be expanded in a laboratory.
Stem Cell Treatments - Q3
Suggest including a short summary of how patients are recruited onto clinical trials, so they are aware of the following:
  • patient’s do not pay for treatment on a clinical trial
  • depending on the clinical trial, they may not receive the treatment but will be monitored (placebo group)
  • they may not be eligible for the clinical trial and why this is important. 
Frequently Asked Questions - Q4
  1. Suggest altering the first paragraph to include:

Unproven stem cell treatments are available in Australia and overseas. Most of the treatments being offered in Australia and overseas are not backed by scientific evidence or through a clinical trial. It is difficult to evaluate the long-term effects of these treatments as the clinics do not make their procedures publically available. Therefore, it could be harder for your doctor, if anything goes wrong or you require follow up advice or treatments. Further, it could be that you won’t be eligible to take part in a clinical trial in the future. Similar to overseas clinics, the Australian-based clinics advertise online.

  • Patients should be wary of clinics that advertise one type of ‘stem cell’ treatment for many different types of diseases or for diseases where the aetiology is unknown.
  • Provide a step-by step guide to how patients can find out whether a ‘stem cell’ treatment has TGA approval. (footnote 3 is incorrect).
  • Some clinics offering unproven ‘stem cell’ treatments advertise ethical approval or oversight. A short explanation of what this involves would be useful for patients, to include that this does not ensure the treatment is proven for efficacy.

Page reviewed: 7 February, 2014